FDA grants breakthrough device designation to hypothermic therapy for concussion

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In an effort to improve current unmet medical needs for athletes, the US Food and Drug Administration (FDA) has approved a non-invasive hypothermic therapy device intended to decrease the severity of concussion symptoms and help patients get back to their pre-injury baseline. According to an article in NS Medical Devices, the pro2cool technology, developed by TecTraum, is the first-ever FDA-approved medical device treatment for concussions. 

Hypothermic therapy is a non-invasive treatment for concussion, in which the head or body is cooled below normal body temperature. Researchers investigating the pro2cool™ device have observed significant improvements in clinical outcomes through the cooling of the brain within eight days of the concussion,” according to the pro2cool website. Hypothermic therapy is clinically effective in cardiology, including cardiac arrest and heart attack. TecTraum’s device “has been designed for localised cooling for the head and neck to reduce blood temperature before it enters the brain.” It is in the final stage of completing a large multi-site clinical trial designed to evaluate the effectiveness and safety of the therapy. The company plans to commercialize the device in early 2022.

“Concussion is a growing burden, clinically, financially and emotionally, in the US,” states lead investigator Joseph Congeni. While the initial aim of the treatment device is to help the unfulfilled medical needs of athletes, the company hopes to expand to other populations that suffer concussions. In the future, hypothermic therapy may help people who suffer concussions caused by motor vehicle accidents, falls, or military service.